[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06385171":3,"trial-entities:NCT06385171":109,"trial-summary:NCT06385171":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":22,"eligibility_criteria":54,"std_ages":84,"locations":87,"central_contacts":102,"overall_officials":103,"references":107,"see_also_links":108},"NCT06385171","FFA-BTX-1","Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation","WITHDRAWN","2027-01-05","2026-08","2026-08-12","2024-05-22","Global Aesthetics LLC","OTHER",true,"A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable.","The primary purpose of this clinical trial is to evaluate the efficacy and safety of Botulinum Toxin Type A in the treatment of facial wrinkles among a diverse population, with a specific aim to bridge the gap between cosmetic injectables and varying financial statuses of potential patients. This study intends to determine the degree to which Botulinum Toxin Type A can reduce the appearance of facial wrinkles, identify the optimal dosage for significant cosmetic improvement with minimal side effects, and assess patient satisfaction with the outcomes. By conducting a rigorous, controlled, and open label methodology, this research aspires not only to provide comprehensive data supporting the use of Botulinum Toxin Type A as a safe and effective treatment for aesthetic improvement but also to make such treatments more accessible and affordable. This endeavor seeks to democratize cosmetic enhancements, ensuring that individuals across different economic backgrounds can benefit from advancements in cosmetic dermatology. Ultimately, the study aims to offer valuable insights into cost-effective practices without compromising treatment quality, thereby enhancing patient care practices and contributing significantly to the field of cosmetic dermatology.",[18],"Wrinkle",[20],"Facial Wrinkles","OBSERVATIONAL",null,[],{"count":25,"type":26},0,"ACTUAL",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Botulinum toxin type A","The intervention involves the administration of Botulinum Toxin Type A, with dosages regulated according to FDA guidelines. Each injection site will receive a maximum of 4 units, adhering to the FDA's recommended dosage limits. Dosages administered will be tailored to each patient's needs and will be recorded in their individual patient information chart.",[33],"Single Group Assignment",[35],"OnabotulinumtoxinA",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Change in facial wrinkles and Lines","Visual Assessment: The Principal Investigator (PI) will visually assess the change in wrinkles and lines on the patient's face compared to baseline, using the following grading scale:\n\nGrade 0: No improvement in wrinkles. Grade 1: Minimal improvement, slight reduction in wrinkles. Grade 2: Moderate improvement, noticeable reduction in wrinkles. Grade 3: Significant improvement, substantial reduction in wrinkles.\n\nAssessment of Change in Wrinkles and Lines:\n\nPhotographic Documentation: Before and after photographs will be taken to objectively compare the appearance of facial wrinkles and lines. The improvement will be graded using the following scale:\n\nGrade 0: No change or worsening of wrinkles. Grade 1: Slight improvement, minimal reduction in wrinkles. Grade 2: Moderate improvement, visible reduction in wrinkles. Grade 3: Significant improvement, marked reduction in wrinkles.","Upto 2 years",{"measure":42,"description":43,"timeFrame":40},"Facial Appearance","Patients will provide feedback on their satisfaction with the treatment outcome and perceived changes in their facial appearance.",{"measure":45,"description":46,"timeFrame":40},"Assessment of Wrinkle Severity","The WSRS will rate the severity of wrinkles on a scale of 1 to 5, with 1 indicating no wrinkles and 5 indicating severe wrinkles.",[48],{"measure":49,"description":50,"timeFrame":40},"Assessment of Skin Reaction","The Principal Investigator (PI) will measure the presence and severity of skin reactions using a grading scale, where:\n\nGrade 0 represents no skin reaction, Grade 1 represents mild redness or inflammation, Grade 2 represents moderate redness or inflammation, and Grade 3 represents severe redness, inflammation, or swelling. By assigning a numerical value to skin reactions, the PI will quantify the degree of immune response, allowing for measurable comparisons over time.","ALL","20 Years","65 Years",{"inclusion":55,"exclusion":61,"raw_text":83},[56,57,58,59,60],"Individuals of both genders.","Must be in good physical health.","Age between 20 and 65 years.","Presence of both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region.","Must possess the willingness and ability to understand and provide informed consent, as well as effectively communicate with study personnel.",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"Pregnant or breastfeeding female.","Age below 20 or above 65 years.","History of neuromuscular disorders, such as myasthenia gravis.","History of facial surgery or presence of scars in the treatment area that could potentially interfere with or confound the results of the study.","Recent treatment history within the past 6 months in the forehead or glabellar region, including:","Ablative laser procedures.","Radiofrequency device treatments.","Ultrasound device treatments.","Medium to deep chemical peels.","Temporary soft tissue augmentation.","Semi-permanent soft tissue augmentation within the past 2 years.","Permanent soft tissue augmentation.","Planned cosmetic procedures within the next 6 months in the same region.","Intended use of tretinoin or retinoic acid within the next 6 months.","Presence of active infection in the treated area, excluding mild acne.","Allergy to cow's milk protein or albumin.","Use of aminoglycoside medications.","Current use of anticoagulation therapy.","History of bleeding disorders.","Diagnosis of mental illness.","Inability to comprehend the study protocol or provide informed consent.","Inclusion Criteria:\n\n* Individuals of both genders.\n* Must be in good physical health.\n* Age between 20 and 65 years.\n* Presence of both static (unchanging) and moderate dynamic (movement-induced) wrinkles on the forehead or glabellar region.\n* Must possess the willingness and ability to understand and provide informed consent, as well as effectively communicate with study personnel.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding female.\n* Age below 20 or above 65 years.\n* History of neuromuscular disorders, such as myasthenia gravis.\n* History of facial surgery or presence of scars in the treatment area that could potentially interfere with or confound the results of the study.\n* Recent treatment history within the past 6 months in the forehead or glabellar region, including:\n* Ablative laser procedures.\n* Radiofrequency device treatments.\n* Ultrasound device treatments.\n* Medium to deep chemical peels.\n* Temporary soft tissue augmentation.\n* Semi-permanent soft tissue augmentation within the past 2 years.\n* Permanent soft tissue augmentation.\n* Planned cosmetic procedures within the next 6 months in the same region.\n* Intended use of tretinoin or retinoic acid within the next 6 months.\n* Presence of active infection in the treated area, excluding mild acne.\n* Allergy to cow's milk protein or albumin.\n* Use of aminoglycoside medications.\n* Current use of anticoagulation therapy.\n* History of bleeding disorders.\n* Diagnosis of mental illness.\n* Inability to comprehend the study protocol or provide informed consent.",[85,86],"ADULT","OLDER_ADULT",[88,96],{"facility":12,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Cisco","Texas","76437","United States",{"lat":94,"lon":95},32.38819,-98.97923,{"facility":12,"city":97,"state":90,"zip":98,"country":92,"geoPoint":99},"Lubbock","79413",{"lat":100,"lon":101},33.57786,-101.85517,[],[104],{"name":105,"affiliation":12,"role":106},"Otis Scroggins, BS, CNA","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Wrinkled face",[],{"nct_id":4,"found":14,"summary":114,"prompt_version":122},{"design":115,"status":116,"heading":6,"summary":117,"follow_up":115,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"Not specified.","completed","{\n   \"Observational Study of Botulinum Toxin Type A for Facial Wrinkles\",\n   \"This study is looking at how well Botulinum Toxin Type A (often called Botox) works to reduce facial wrinkles. Researchers want to see if this treatment is safe and effective for making wrinkles on your forehead or between your eyebrows less noticeable. They also want to find the best dose and make these treatments more affordable. You might be able to join if you are between 20 and 65 years old, in good health, and have both static (always there) and dynamic (when you move your face) wrinkles. The study will measure changes in your wrinkles and how your face looks for up to two years. The current recruitment status is unclear, but they plan to enroll 500 people.\",\n  \"design\": \"This is an observational study that plans to enroll 500 participants. It is an open-label study, meaning both you and the researchers will know you are receiving Botulinum Toxin Type A.\",\n  \"commitments\": \"You will receive injections of Botulinum Toxin Type A, with each injection site getting a maximum of 4 units. Your facial wrinkles and appearance will be assessed for up to two years.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Your facial wrinkles, appearance, and wrinkle severity will be assessed for up to two years after the treatment.\",\n}",222,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]